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The Food and Drug Administration (FDA) on Friday approved the first drug specifically designed to treat smallpox – despite the fact that the disease was officially eradicated in 1980.
While the daily threat of smallpox, which is caused by FDA Commissioner Scott Gottlieb, said in a statement that the drug, called TPOXX, or tecovirimat, could be a protection against bioterrorism.
"To counteract the risk of bioterrorism, Congress has allowed the development and approval of countermeasures to counteract the pathogens that could be used as weapons," Gottlieb said. "Today's approval is an important step in these efforts, and this new treatment offers us an additional option if smallpox is used as a biological weapon."
The efficacy of TPOXX has been tested on animals with FDA-based variola virus-like viruses, which states that well-designed animal studies can be used instead of human tests when it would not be safe or ethical to test an animal. drug on people. The safety of the drug was also tested on nearly 360 human volunteers, who had no smallpox.
Tecovirimat, which is manufactured by SIGA Technologies Inc., is the first of a series of upcoming approvals aimed at reducing the risk of bioterrorism, Gottlieb Gottlieb said: "The action of Today, this reflects the FDA's commitment to ensuring that the United States is ready for any eventuality. public health emergency with timely, safe and effective medical products. "
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